MAUDE Adverse Event Report: COOK INC TORNADO PLATINUM EMBOLIZATION MICROCOIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hepatitis (1897); Itching Sensation (1943); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): line 2 - direct supplies/ medical devices, phone: (b)(6).Date of event: event occurred in mid march, approximately 3 weeks after the procedure pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported a 61 year old, male patient underwent embolization of the right renal artery in preparation for a kidney transplant.Under anesthesia, the patient received microspheres distally and then occlusion using two 5/2 tornado platinum embolization microcoils, one 6/2 tornado platinum embolization microcoil, and one 5/3 tornado platinum embolization coil.Beginning in mid march, approximately three weeks after embolization, the patient experienced worsening, disabling pruritus and insomnia.Additionally, the patient is experiencing complicated subacute anicteric cholestatic hepatitis.Additionally, a list of the patient's treatments introduced in 2022 was provided.This list included treatments used during embolization: lidocaine; general anesthesia with ephedrine, propofol, ringer's lactate, sufentanil, ketoprofen, tramadol, midazolam, and droperidol; nefopam on (b)(6); methylprednisolone and cefazolin on (b)(6) 2022; sufentanil/droperidol from (b)(6); then at home analgesic treatment with paracetamol 1g x3/day and phloroglucinol, and tramadol 50mg x 3 / day if pain persists.It was also noted that amoxicillin was given in (b)(6) 2021 and an increase in alkaline phosphatase was noted in the follow-up in (b)(6) 2022.Desloratadine was also listed.The patient's cholestasis has been managed by ursodeoxycholic acid since (b)(6) 2022 and rifampin 1/d on (b)(6) 2022 for pruritus (the dose was increased on (b)(6) 2022 to 600mg/d, allowing an almost total regression of pruritus).As of may 2022, this patient's home treatment consisted of bilastine, bisoprolol, perindopril, esomeprazole, urapidil, sodium polystyrene sulfonate, pravastatin, folic acid, vitamin d, and on dialysis he received epoetin and enoxaparin.He is vaccinated against sars-cov-2 last injection in (b)(6) 2021.He was vaccinated against influenza in october 2021.No other adverse effects were reported.The patient's current status was last provided as hospitalized.The three lots of tornado coils recorded in this incident are reported under patient identifiers (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received providing official translation of the customer documents.It was clarified that the patient¿s alanine transaminase (alts) and aspartate transaminase (asts) increased following amoxicillin administration in april 2021.It was noted the patient has not had any fever, flu-like symptoms, or digestive symptoms.Total bilirubin is still below 10 mg/l.It is noteworthy that crp increased to a peak of 59 mg/l on 16/03/2022, and later decreased.

Event Description

In additional information, it was reported the coils are still implanted in the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, this event is not reportable.There is no information to indicate device malfunction or serious injury.It was determined that the described symptoms are not life-threatening nor are they likely to result in permanent impairment for the patient.Additionally, there were no interventions performed to prevent permanent impairment or death of the patient as a result of this event.A detailed search of complaint history has revealed no previous, similar occurrences.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.

• Brand Name: TORNADO PLATINUM EMBOLIZATION MICROCOIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15352334
• MDR Text Key: 299211526
• Report Number: 1820334-2022-01453
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00827002083561
• UDI-Public: (01)00827002083561(17)260425(10)13911254
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCE-18S-5/2-TORNADO
• Device Lot Number: 13911254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MERIT MEDICAL EMBOGOLD MICROSPHERES 100-300M.; MWCE-18S-6/2-TORNADO.; MWCE-35-5/3-TORNADO.
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male